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Tag: Mifepristone

  • Fact-checking Florida AG on abortion pill hospitalizations

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    Florida Attorney General James Uthmeier is suing Planned Parenthood for what he called deceptive marketing practices involving abortion pills.

    In a Nov. 6 video on X, Uthmeier said Planned Parenthood “falsely marketed to women” that abortion pills are safer than over-the-counter medications.

    “Evidence suggests that 1 in 25 women who consume these dangerous pills are hospitalized,” Uthmeier said. “And we’ve seen dozens of reported deaths. This is wrong, and we’re going to hold them accountable.”

    Although Uthmeier used the word “hospitalized” to describe the outcome, text that appeared on screen in the video as he spoke said 1 in 25 women “end up in the ER,” a figure that combines results from two studies Uthmeier cited. Emergency department visits are not the same as hospitalizations, which involve patients being formally admitted. 

    When contacted for evidence, Uthmeier’s spokesperson pointed PolitiFact to a table in the U.S. Food and Drug Administration’s label for mifepristone, the first of two pills taken in early pregnancy for medication abortion. One line in the table said two U.S. studies with 1,043 women found a 2.9% to 4.6% frequency rate for ER visits. The higher end of the range roughly correlates to 1 in 25 women.

    Besides conflating hospitalizations and ER visits, Uthmeier cited studies with small sample sizes; multiple larger studies found lower rates of both ER visits and hospitalizations following medication abortion. Researchers told PolitiFact emergency department visits are not a reliable indicator of drug safety and are not proof that patients experienced serious adverse events or were admitted to the hospital.

    “In large studies of medication abortion, hospitalization is very rare, generally occurring in <0.5% of patients,” Dr. Daniel Grossman, a professor of obstetrics, gynecology and reproductive sciences at the University of California, San Francisco, wrote in an email to PolitiFact. Grossman said ER visits are more common because patients who do not live near their provider might have to go to an emergency department for anything that requires in-person consultation, including to confirm an abortion was successful. 

    The FDA label that Uthmeier cited also showed hospitalization rates of 0.04% to 0.06% among 14,339 women evaluated in three studies, or about 86 women on the higher end of the range.

    The FDA label does not include the research methodology or details about the cases. The FDA didn’t answer our questions about the studies.

    Danco Laboratories, which manufactures and distributes mifepristone under the brand name Mifeprex, provided the studies to PolitiFact. The two reports showed 41 women out of 1,043 visited the ER after taking abortion pills. Eight of the 41 were hospitalized and, of those, three were admitted for unrelated reasons, including pancreatitis and hip pain. That means five out of 1,043 women evaluated were hospitalized for reasons related to abortion pills.

    “The actual percentage of related serious adverse events that required hospital admission in these two studies was 0.5%,” said Ushma Upadhyay, a professor and public health scientist at the University of California, San Francisco.

    What is medication abortion and how safe is it?

    Medication abortion is approved in the U.S. up to the 10th week of pregnancy and involves two medicines — mifepristone and misoprostol — that are typically taken 24 hours apart. Studies have found that around 95% to 98% of patients who take the medicines as prescribed will end their pregnancies without  complication.

    The FDA has repeatedly reaffirmed mifepristone’s safety since the drug was first approved in 2000. (Misoprostol has been on the market longer and has different uses, including preventing stomach ulcers.)

    Medication abortions are common, accounting for 63% of all abortions in the U.S. in 2023, according to the Guttmacher Institute, a research organization that supports reproductive rights. More than 5 million women in the U.S. have used abortion pills to terminate pregnancies.

    Over 100 studies spanning decades have found medication abortion to be safe and effective. 

    “We’ve been using mifepristone in the U.S. for over two decades and we aren’t seeing legitimate studies that are documenting any medical fallout or medical complications from this drug,” said Rachel Jones, Guttmacher Institute principal research scientist.

    Medication abortion and ER visits, hospitalizations

    Research shows abortion pills are not associated with a high percentage of emergency room visits or hospitalizations.

    The studies Uthmeier pointed to did not prove that medication abortion is dangerous, experts said

    One of the studies, published in 2012, acknowledged that major adverse events attributable to medication abortion, such as hospitalizations, emergency department visits and blood transfusions, are “rare.” 

    The vast majority of mifepristone research is in line with this.   

    A 2013 study that examined 233,805 medication abortions by Planned Parenthood in 2009 and 2010 found an emergency department treatment rate of 0.1%, and said significant adverse events requiring hospital admission occurred in 0.16% of cases.

    A 2015 study on emergency room visits and complications after 55,000 abortions — 11,000 of which were medication abortions — found that serious adverse events occurred in 0.3% of all cases.

    Emergency department visits alone are not indicative of adverse events, Upadhyay, the 2015 study’s lead author, told PolitiFact.

    A 2018 study found around 51% of abortion-related ER visits involved observational care only. “This really shows that people go to the emergency department to have their questions answered. They aren’t getting any treatment. They are being observed and released,” Upadhyay said.

    U.S. Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary have promised to launch another mifepristone safety review. The top health officials have referenced studies that experts say have several problems.

    For example, one April report by the Ethics and Public Policy Center, a conservative nonprofit that opposes abortion, found a substantially higher rate of serious side effects from the drug compared with other studies.

    The report wasn’t peer-reviewed or published in a medical journal. It didn’t disclose its data source and contained multiple methodological issues, 263 reproductive health researchers wrote in a letter to the FDA. Uthmeier cites the report in Florida’s lawsuit against Planned Parenthood.

    Our ruling

    Uthmeier said, “Evidence suggests that 1 in 25 women who consume (abortion) pills are hospitalized.”

    Uthmeier conflated hospitalizations with emergency department visits. Roughly 1 in 25 women visited the ER in the two studies Uthmeier cited, but only five out of 1,043 — or 1 in 200 — were hospitalized related to the abortion pill.

    ER visits, which can often involve only observational care followed by release, are not a reliable indicator of drug safety, researchers said, and do not mean patients experienced a serious adverse event or were admitted to the hospital.

    Several other studies found lower rates of ER treatment and hospitalizations following medication abortion.

    Uthmeier’s statement contains an element of truth but ignores critical facts that would give a different impression. We rate it Mostly False.  

    PolitiFact Researcher Caryn Baird contributed to this report.

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  • Republican fury after FDA approves abortion pill: ‘Complete betrayal’

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    Several Republican figures have spoken out against the Donald Trump administration’s approval of an abortion pill, with former Vice President Mike Pence calling it a “complete betrayal of the pro-life movement.”

    The Food and Drug Administration (FDA) gave the green light to a new generic version of mifepristone on Tuesday, Drugmaker Evita Solutions announced on its website.

    Pence is one of multiple conservatives who have criticized the move—he called on Trump to reverse the decision.

    Newsweek has contacted the FDA and Evita Solutions, via email, for comment.

    Why It Matters

    The decision has ignited intense backlash from Republican lawmakers and anti-abortion groups, highlighting the enduring divisiveness of abortion policy in the United States.

    It comes amid ongoing legal and political battles over reproductive rights and federal drug approval authority.

    Mifepristone, first approved in 2000, is used in combination with misoprostol for medication abortions, a method accounting for the majority of abortions nationwide.

    The FDA’s action not only stokes political tensions but also underscores the complexities of drug regulation where ideological and medical considerations intersect.

    What People Are Saying

    Pence, who has repeatedly criticized Trump in the aftermath of the January 6 riots, said in a post on X: “The Trump Administration’s approval of a generic chemical abortion drug is a complete betrayal of the pro-life movement that elected President Trump.

    “Earlier this year, I opposed RFK’s nomination because he was unfit for the role and particularly over the concern that he would expand access to abortion, as he has done today.

    “President Trump must immediately reverse this decision. RFK must resign and give President Trump the opportunity to appoint a new Secretary of HHS who will protect the sanctity of life. The fight for life continues.”

    Missouri Republican U.S. Senator Josh Hawley said on X: “This is shocking. FDA has just approved ANOTHER chemical abortion drug, when the evidence shows chemical abortion drugs are dangerous and even deadly for the mother. And of course 100% lethal to the child.

    “FDA had promised to do a top-to-bottom safety review of the chemical abortion drug, but instead they’ve just greenlighted new versions of it for distribution. I have lost confidence in the leadership at FDA.”

    Oklahoma Republican Congressman Josh Brecheen said: “The FDA just approved the generic counterpart for mifepristone, the abortion pill. Abortion is one of the defining evils of our time, and we must acknowledge that it is murder in every form. 1 in 10 women who take the abortion pill face serious complications, at a rate 22x higher than initially reported by the FDA. How can this be considered safe for unborn children or women?”

    Prominent anti-abortion activist Lila Rose said: “UNACCEPTABLE: The FDA just approved another generic of the abortion pill mifepristone. This drug starves babies and harms mothers! The FDA just said it would do a new serious safety study—so why approve a another generic now?  Robert Kennedy Jr. must reverse this decision!”

    Reproductive Freedom for All account posted on X: “The FDA approved a new generic version of mifepristone, a pill that has been safely and effectively used in abortion and miscarriage care for over two decades. Thank you to the civil servants who made this happen.”

    What To Know

    In a letter to Republican attorneys general last month, Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary pledged to conduct a full review of mifepristone, which was approved 25 years ago and has repeatedly been deemed safe and effective by FDA scientists.

    Generic approvals are usually considered routine. After the patent on the original drug expires, multiple drugmakers often enter the market with cheaper versions. To receive approval, companies must demonstrate that their product is chemically identical to the original. In most cases, such reviews are completed within 10 months.

    But Evita’s application took far longer. According to FDA filings, the company submitted its request four years ago. The FDA did not explain the delay.

    What Happens Next

    Approval of Evita’s pill is not expected to significantly alter access to mifepristone. The medication is typically prescribed with misoprostol, a second drug that causes the uterus to contract and empty. Together, the two drugs account for roughly two-thirds of U.S. abortions. Mifepristone blocks the hormone progesterone and softens the cervix to prepare the body for expulsion.

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  • Kennedy says FDA is reviewing safety of abortion pill mifepristone

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    The Food and Drug Administration is reviewing the safety of the abortion pill mifepristone, Health and Human Services Secretary Robert F. Kennedy Jr. said in a recent letter to Republican state attorneys general. 

    Conservatives and anti-abortion groups have criticized the drug, particularly after the Biden administration in 2023 made it possible for women to receive mifepristone via telehealth and by mail. The majority of women who terminate pregnancies do so through medication abortions. 

    Republican attorneys general had written to Kennedy on the matter in July, and in response, Kennedy said the FDA is taking a look at the drug’s Risk Evaluation and Mitigation Strategy. Kennedy in June asked FDA Commissioner Martin Makary to “review the latest data” on the drug, an FDA spokesperson confirmed at the time. The spokesperson did not respond to further questions about when the review would start or what specifically it was reviewing about the drug. 

    In their Sept. 19 letter to the states, Kennedy and Makary wrote, “HHS — through the FDA — is conducting its own review of the evidence, including real-world outcomes and evidence, relating to the safety and efficacy of the drug.” 

    “Recent studies — such as the study by the Ethics and Public Policy Center (EPPC), which you highlighted in your letter — indicate potential dangers that may attend offering mifepristone without sufficient medical support or supervision,” the letter continued. “FDA’s own data collected between 2000 to 2012 indicated 2,740 adverse events, including 416 events involving blood loss requiring transfusions. Since then, safeguards for women regarding the administration of mifepristone have been significantly reduced.”

    According to EPPC, its study found nearly 11% of women “experience sepsis, infection, hemorrhaging, or another serious adverse event within 45 days following a mifepristone abortion,” but CBS News medical contributor Dr. Celine Gounder told “CBS Evening News,” “Other data sources show the rate of serious complications to be much lower, at less than 1 in 200.”

    The EPPC study cited by Kennedy and lawmakers like Sen. Josh Hawley of Missouri, is one that says it focuses on “applying the Judeo-Christian moral tradition” to public policy. 

    Asked whether the review could lead to a ban on mifepristone, Gounder suggested it would be difficult for the FDA to withdraw approval, an extraordinary step that would quickly draw legal challenges, but said depending on what the safety review finds, it could make access more difficult, limiting the drug’s availability through telehealth or by mail, or restricting the ability to prescribe it to doctors, rather than physician assistants or nurses who are also currently able to prescribe it.

    Kennedy and Makary did not say when their review would be completed, but told the states, “We will keep you informed as the FDA’s review of mifepristone progresses.”

    Advocates of access to the abortion pill insist it’s safe.

    “More than 100 studies confirm mifepristone’s exceptional safety record,” the American Civil Liberties Union said in a statement in response to the mifepristone safety review. “Today, medication abortion accounts for nearly two-thirds of abortions in the U.S, and the nation’s leading medical associations now stress mifepristone’s importance not only for abortion but for miscarriage care as well.”

    Mifepristone is approved to terminate a pregnancy through 10 weeks of gestation. It was first approved by the FDA in 2000, and has, according to the ACLU, been used by more than 7.5 million women since then. 

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  • U.S Supreme Court Rejects Challenge to Abortion Pill, Allows it to Stay on the Market

    U.S Supreme Court Rejects Challenge to Abortion Pill, Allows it to Stay on the Market

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    On Thursday, the U.S Supreme Court rejected a challenge to restricting access to the abortion drug, Mifepristone, effectively shutting down a plea by a group of physicians with anti-abortion views to block circulation of the widely-used pill.

    The court ruled unanimously that medical professionals from the Alliance for Hippocratic Medicine — the lead plaintiff in the case — did not have legal standing to request the reversal of the U.S. Food and Drug Administration’s long-standing approval of the drug or call for additional restrictions on its usage.

    The decision will keep the medication available in states where abortion is legal. Notably, per Texas’s near-total ban on abortion, it will not be available in state Texas to residents.

    Mifepristone will remain accessible via telehealth services, can continue to be distributed by mail and it will not be illegal to take the two-step regimen — misoprostol is the accompanying drug — after the seventh week of pregnancy. The regulated usage protocol will stay the same.

    However, the case will be sent back to the district court, and litigation is likely to continue. U.S. District Judge Matthew J. Kacsmaryk initially ruled to revoke the FDA’s approval of Mifepristone and place additional restrictions on the pill.

    “They are sending this decision back to the lower courts,” Dr. Bhavik Kumar, medical director of primary and trans care at Planned Parenthood Gulf Coast, said. “So, it remains unknown exactly what that means and what that outcome will be.”

    Kumar referred to Thursday’s decision as a “frustrating win.” He said medical professionals, abortion advocates and legal experts have known from the start of this case that the plaintiffs had no legal standing.

    According to Kumar, the group of physicians were able to “cherry-pick” their way through the lower courts to get the matter before the country’s highest court, “We shouldn’t even be here right now,” he said.

    Legal experts questioned what the decision could also mean for other medications on the market. Protect Our Care, a health care advocacy group, noted that the choice could have thrown the entire U.S. drug approval process into chaos.

    Amy O’Donnell, communications director with Texas Alliance For Life, said the pro-life organization expected Thursday’s ruling after the justices discussed legal standing during a March hearing.

    Despite not being surprised by it, O’Donnell noted that it was disappointing and put the health, lives and future fertility of women and girls in the country at risk.

    “This is not the end of the conversation. There are other avenues for us to seek a reversal of those lax guidelines,” O’Donnell said. “We — the pro-life community — can petition to the executive branch. We can seek other ways to go about what the physicians and organizations, in this case, were trying to achieve.”

    O’Donnell and other pro-life advocates take issue with what they refer to as an increased risk of complications linked to medical abortions compared to those associated with surgical abortions.

    Medical professionals often reject this claim and cite the FDA’s 24-year-old approval of Mifepristone.

    “It has been proven safe and effective,” Kumar said. “Over 5 million people have used it, and medical abortions account for 63 percent of all abortions in the United States.”

    Although some in the reproductive rights community view Thursday’s decision as a small reprieve from the ongoing attacks on reproductive health care, many are awaiting the highest court’s next ruling on a case out of Idaho.

    The case challenges whether a federal law — the Emergency Medical Treatment and Active Labor — that requires emergency stabilizing care, including abortions, overrides Idaho state mandate that only permits these procedures if, without them, a person could die.

    Justices heard oral arguments in the case in late April, and a ruling on the matter is pending.

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    Faith Bugenhagen

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  • The court can’t stop abortion pills

    The court can’t stop abortion pills

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    Ezra Dickinson , Shout Your Abortion

    A wheatpaste message from Shout Your Abortion reads, “Fuck The Courts Abortion Forever.”

    On Tuesday, the United States Supreme Court took a decisive step in the long-standing controversy over abortion post-Roe v. Wade by examining the regulatory framework surrounding mifepristone, a key drug in medical abortion protocols. This case, spotlighted for its profound implications on reproductive healthcare and the regulatory authority of the FDA, underscores the ongoing and contentious battle over abortion access in America.

    The case concerns the regulation and access to mifepristone, a drug used in the majority of medical abortions across the nation. Initiated by the Texas-based Alliance for Hippocratic Medicine against the FDA’s policies, the dispute highlights significant disagreements on the safety, oversight, and accessibility of the abortion pill. These policies, which have been liberalized over the years, now allow the drug to be prescribed via telemedicine and mailed directly to patients. The challenge questions both the FDA’s original approval of mifepristone for abortion and its subsequent decisions to ease access restrictions, implicating broader debates over reproductive health care, regulatory authority, and the impact of judicial decisions on medical practice.

    The defendants in the case, represented by the Biden administration and Danco Laboratories (the distributor of mifepristone), argued strongly in favor of maintaining access under the FDA’s current regulations. They contended that the lower court rulings, which sought to restrict access to the drug, were unprecedented and contradicted the FDA’s scientific judgment. The administration emphasized the potential regulatory chaos and significant impacts on healthcare access that could arise from upholding these rulings. They highlighted that the drug’s safety profile is well-documented, with a complication rate lower than many over-the-counter medications, and warned that curtailing access to mifepristone could undermine trust in the regulatory framework and affect other medications, including contraceptives and vaccines. Danco Laboratories, meanwhile, described the situation as an “untenable limbo,” arguing that without the FDA approvals, they would not be able to legally market and distribute the drug, further complicating access for those in need.

    The prevalence of medication abortions in the U.S. underscores their significance in reproductive healthcare. The Centers for Disease Control and Prevention (CDC) reported that, as of 2021, medication abortions accounted for 56% of all abortions in the U.S., marking a rise from previous years. Mifepristone, used in combination with misoprostol for medical abortion, has a well-documented safety record supported by decades of data and is approved for use in nearly 100 countries. Since its FDA approval in 2000, extensive evidence has demonstrated mifepristone’s safety and effectiveness, showing it to be a crucial component of reproductive healthcare. It’s a part of the World Health Organization’s list of essential medicines due to its role in decreasing the incidence of unsafe abortions and is considered safe for use through ten weeks of gestation.

    The FDA announced in April 2021 that it would temporarily allow abortion pills, including mifepristone, to be mailed to patients during the COVID-19 pandemic. This decision facilitated the prescription of mifepristone via telehealth by enabling patients to receive the medication without requiring an in-person visit to a healthcare facility. Following this temporary allowance, in December 2021, the FDA issued a permanent decision to allow the mailing of abortion pills, expanding access through telehealth and pharmacies.

    This move by the FDA was supported by extensive research demonstrating that telemedicine abortions are as safe and effective as in-person care. A large multi-state study, for instance, analyzed records from nearly 6,000 patients receiving medication abortion either through telemedicine or in person and found that outcomes for medication abortion via telemedicine are comparable with those provided in person, with very rare complications​.

    Furthermore, even in states where abortion access is heavily restricted, telehealth has continued to rise as a critical means for patients to obtain necessary care. Studies and organizations advocating for reproductive rights have emphasized the importance of telehealth in maintaining access to abortion pills, highlighting its safety and effectiveness, and noting that more Americans are using telehealth to access or even stockpile abortion pills in anticipation of future needs​.

    For the majority of Americans, telehealth has emerged as the primary, if not sole, avenue for accessing abortion care. This trend is not limited to states where abortion services have been heavily restricted or outright criminalized. In rural areas, such as those found in Northern Michigan, the challenges of geographical isolation and scarcity of healthcare providers compound the issue, making telehealth a crucial option for those seeking abortion care.

    The financial impact of in-clinic abortions, often exceeding $600 per procedure, significantly burdens those seeking abortion care. This cost does not include additional financial pressures such as lost wages from taking time off work, travel expenses to the clinic, and, when necessary, accommodations for overnight stays due to distant providers. These accumulated costs render in-clinic abortions a challenging option for many, particularly in areas even with several clinics, such as metro Detroit. Here, despite the availability of clinics, the high costs of procedures often present an insurmountable barrier, making medication abortion a more viable option. Offering a cost-effective solution for those navigating financial obstacles, medication abortions are available online, with prices ranging from no cost up to $150. The medications are delivered directly to homes, representing a practical alternative for individuals unable to afford clinical care.

    Although medication abortion is demonstrated to be safer than widely prescribed medications such as penicillin and Viagra, the contention surrounding it is driven not by its medical application but rather by its political implications. The truth is that the anti-choice movement perceives abortion medication delivered via telehealth as a significant loophole, representing a modern method for ensuring abortion access despite legislative restrictions. Despite the availability of evidence showcasing its effectiveness and safety, as well as data highlighting the adverse outcomes of denying access to abortion, opponents of abortion rights persist in advancing their agenda, regardless of the consequences for the health and well-being of those seeking care and their families.

    During Tuesday’s oral arguments, the Supreme Court appeared inclined to reject challenges to the availability of abortion pills.

    The litigants maintain that attending to patients who have used abortion medications violates their personal moral and religious convictions, and while Supreme Court Justice Ketanji Brown Jackson and Solicitor General Elizabeth Prelogar emphasized that the plaintiffs’ ethical dilemmas are already mitigated by established federal conscience protections, the lawsuit seeks to impose stringent restrictions on these medications, which would restrict availability to all people in the U.S. The court appeared skeptical about the necessity to amend FDA regulations universally just to accommodate the concerns of a specific group.

    The final decision is likely to remain uncertain until June, when the Court typically announces its rulings on highly debated cases. In the meantime, we can take away that the anti-choice movement is strategically targeting the scientific and regulatory underpinnings of abortion rights, focusing on legal challenges and efforts to sway public opinion to restrict access to abortion services.

    The anti-choice movement’s tactics align with its long-standing approach of disseminating misleading information about abortion medication and organizations like Planned Parenthood, as well as their widespread success in restricting access to comprehensive sexual education and establishment of so called “Crisis Pregnancy Centers,” which masquerade as legitimate abortion clinics but instead aim to dissuade individuals from seeking abortion care through misleading counseling and information.

    Republican voters, particularly those with strong evangelical beliefs, have significantly influenced the GOP’s stance on abortion, despite representing the minority of Americans who oppose abortion access. This focus has led to a strategic alignment with anti-abortion policies, aiming to secure and mobilize the evangelical base in support of Republican candidates, as seen in recent election cycles. This strategic alignment underscores a prioritization of appeasing a specific voter base rather than legislating in the best interest of the country’s citizens based on empirical data and objective analysis.

    While Republicans have undeniably capitalized on the abortion debate for electoral gains, Democrats have also leveraged it to their advantage. For decades, Democrats have campaigned on safeguarding reproductive access, with Vice President Kamala Harris recently launching a “Reproductive Freedoms Tour” as part of the Biden-Harris 2024 campaign. Despite substantial financial investments in supporting pro-choice candidates, the erosion of protections under Roe v. Wade persists. The absence of an effective mechanism to hold elected officials accountable for their campaign pledges suggests that abortion has become a potent rallying point for committed single-issue voters, offering little impetus for either party to seek resolution on the matter.

    However, hope does lie at the end of the tunnel. According to new research published in the medical journal JAMA on Monday, there were about 26,000 more self-managed medication abortions than expected based on pre-Dobbs trends and about half of the pills for self-managed medication abortions were provided by community organizations outside of the formal healthcare system. Community networks supplying abortion pills typically consist of grassroots organizations or advocacy groups operating at local, national, or international levels and provide access to reproductive healthcare, including abortion services, to individuals who may face barriers such as financial constraints, geographical distance from clinics, or legal restrictions.

    These provisions are frequently established outside legal frameworks, ensuring that safe, effective, and affordable abortion medication is accessible to anyone in need, regardless of judicial rulings or current elected officials. Currently, abortion medication is available by mail in all 50 states. Although this form of medication is highly safe, its legal standing in the United States remains precarious. A 2023 study by If/When/How reported that 61 people were criminally investigated or arrested for allegedly ending their own pregnancy 2000 and 2020.

    Given that the criminal justice system disproportionately impacts marginalized communities, it follows that abortion regulations will similarly affect these groups, especially Black individuals and low-income people of color. This pattern suggests that any restrictions or criminalization of self-managed abortions will most heavily impact those already facing systemic inequalities. That’s exactly what the data reported by If/When/How shows. Out of 54 cases that involved adults investigated for pregnancy termination, more than 40% of the cases involved people of color.

    In a significant number of instances, healthcare providers, uncertain about legal obligations and concerned over potential prosecution for complicity, have reported patients to authorities. It’s important to note, however, that no current state or federal legislation mandates medical professionals to report instances of self-managed abortions to law enforcement. Proper patient education on the expected outcomes of medication abortions would likely decrease unnecessary emergency room visits. Moreover, informed patients might refrain from disclosing their use of abortion medication to healthcare staff, as medically, a self-managed abortion is indistinguishable from a miscarriage.

    This implies that irrespective of the Supreme Court case’s resolution, if the anti-choice advocates have managed to sow sufficient doubt regarding the safety and legal status of abortion pills, thereby leaving individuals in need of this essential medication uncertain about its administration or where to seek assistance and healthcare providers unsure of their duties, we are likely to witness a surge in avoidable regulatory crackdowns. This underscores the danger of both restricting access to information on self-managed abortions and spreading misinformation about them. These actions can significantly jeopardize public health and safety, as they contribute to confusion and potential harm among those seeking safe abortion methods.

    Fortunately, comprehensive support networks are being built across the country and expanding to assist individuals, irrespective of legal constraints. Organizations such as Plan C Pills and Aid Access are connecting folks with safe and affordable medication and have committed to providing information about how to obtain abortion pills regardless of what the courts decide. The Miscarriage + Abortion hotline is staffed by doctors with years of experience caring for miscarriage and abortion are available by phone for all questions and concerns throughout an abortion or miscarriage, and the Repro Legal Helpline can answer legal questions about abortion.

    These organizations, along with many others, form a unified front of support, ensuring that everyone, no matter their location, can access abortion pills safely. The truth is, it’s not feasible to limit the distribution of abortion pills via mail. The primary obstacle is simply the unawareness of the existence of these vital resources, and it’s something everyone can participate in.

    Our collective effort is critically needed: Gaining an understanding of how these support networks function and the necessary safety measures is essential. By securing abortion medication in advance, to have it on hand for either personal use or to assist others later, we enhance our shared resource network. By openly sharing this vital information, we can collaboratively work to expand abortion access throughout America for everyone.

    The courts can’t stop us, but we need your help.

    Jex Blackmore is a founding member of Hydra Mutual Aid Fund.

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    Jex Blackmore

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  • Breaking down Supreme Court arguments in abortion pill case

    Breaking down Supreme Court arguments in abortion pill case

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    Breaking down Supreme Court arguments in abortion pill case – CBS News


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    The Supreme Court on Tuesday heard arguments on access to mifepristone, a pill that’s taken with another drug to terminate an early pregnancy. The high court will weigh if the Food and Drug Administration adequately considered safety when it expanded access to the medication in 2016 and 2021. Robin Nunn, a federal trial attorney, joins CBS News with more.

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  • Justice Dept and abortion pill manufacturer ask Supreme Court to hear case on mifepristone access

    Justice Dept and abortion pill manufacturer ask Supreme Court to hear case on mifepristone access

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    Danco Laboratories, the drugmaker of the abortion pill mifepristone, has asked the Supreme Court to review a lower court’s decision limiting access to the pill, the company announced in a news release Friday. On Friday evening, the Justice Department also asked the Supreme Court to review the Fifth Circuit’s judgment. 

    Danco and the Justice Department want the Supreme Court to reverse the circuit court’s ruling that would prevent women from obtaining the drug by mail order and would prohibit the pill after seven weeks of pregnancy. 

    The plaintiffs in the case, a group of physicians and medical associations opposed to abortion rights, say the Food and Drug Administration failed to adequately consider the drug’s safety and “chose politics over science” when it approved the pill in 2000. 

    The Justice Department asserted in its filing Friday that the plaintiffs lack standing in the case, arguing that since they aren’t required to receive or prescribe mifepristone, the FDA’s decision “does not impose any concrete, particularized, or imminent harm on them.”

    The department also argues that The Fifth Circuit’s decision should be reviewed because “it would impose an unprecedented and profoundly disruptive result,” causing “unnecessary restrictions” on a drug that has been “safely used by millions of Americans over more than two decades.” It noted that many rely on mifepristone as an option over surgical abortions for those “who choose to lawfully terminate their early pregnancies.”

    Further, the Justice Department said the Fifth Circuit’s ruling should be reviewed in light of its “serious legal errors,” asserting that the lower court’s “novel ‘standing’ analysis” means that medical associations would be able to file lawsuits “that might incidentally affect the practices of one of their associations’ members.” 

    “Pulmonologists could sue the Environmental Protection Agency to challenge regulations that increased (or reduced) air pollution; pediatricians could sue the Department of Agriculture to challenge standards that imperiled (or improved) student nutrition,” the Justice Department wrote.

    Last month, a three-judge panel of the U.S. Court of Appeals for the Fifth Circuit issued a ruling that allowed the pill to remain legal, but with significant hurdles to patient access. The Fifth Circuit upheld the Food and Drug Administration’s approval of the widely used pill, but said actions the FDA took in recent years to make the pill easier to obtain went too far. 

    An earlier Supreme Court order in April ensured the drug will remain accessible either until the highest court takes up the case and issues a ruling, or turns down a request to review the Fifth Circuit’s decision. 

    The White House has vocally opposed the changes the Fifth Circuit’s decision would make to access to the pill. 

    “Due to the Supreme Court’s stay, mifepristone remains broadly available for now,” White House press secretary Karine Jean-Pierre said after the Fifth Circuit’s decision. “But if the Fifth Circuit’s ruling stands, it will significantly roll back the ability for women in every state to get the health care they need, and undermine FDA’s scientific, evidence-based process for approving safe and effective medications that patients rely on.”

    Melissa Quinn contributed to this report.

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  • What could come next in the legal battle over the abortion pill mifepristone

    What could come next in the legal battle over the abortion pill mifepristone

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    What could come next in the legal battle over the abortion pill mifepristone – CBS News


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    The Supreme Court on Friday ruled that the Food and Drug Administration’s approval of the abortion pill mifepristone can remain in place while legal proceedings play out. James Inman has the details.

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  • CBS Evening News, April 21, 2023

    CBS Evening News, April 21, 2023

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    CBS Evening News, April 21, 2023 – CBS News


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    Supreme Court set to issue ruling on abortion drug mifepristone; Wrongfully convicted man freed after 28 years meets longtime pen pal

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  • Supreme Court temporarily maintains FDA approval of abortion drug mifepristone

    Supreme Court temporarily maintains FDA approval of abortion drug mifepristone

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    Supreme Court temporarily maintains FDA approval of abortion drug mifepristone – CBS News


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    The Supreme Court on Friday granted a Justice Department request to maintain the Food and Drug Administration’s approval of the abortion drug mifepristone while legal proceedings continue. This comes after a lower court judge in Texas halted that FDA approval earlier this month. Jan Crawford has more.

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  • Supreme Court set to issue ruling on abortion drug mifepristone

    Supreme Court set to issue ruling on abortion drug mifepristone

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    Supreme Court set to issue ruling on abortion drug mifepristone – CBS News


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    The Supreme Court has set a deadline of Friday at midnight in which to issue a ruling on whether to preserve Food and Drug Administration approval of the abortion drug mifepristone. This comes after a lower court judge in Texas halted that approval earlier this month. Jan Crawford has the latest.

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  • U.S. Supreme Court preserves near-term access to abortion pill mifepristone

    U.S. Supreme Court preserves near-term access to abortion pill mifepristone

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    WASHINGTON (AP) — The Supreme Court on Friday preserved women’s access to a drug used in the most common method of abortion, rejecting lower-court restrictions while a lawsuit continues.

    The justices granted emergency requests from the Biden administration and New York–based Danco Laboratories, maker of the drug, called mifepristone. They are appealing a lower-court ruling that would roll back Food and Drug Administration approval of mifepristone.

    The drug has been approved for use in the U.S. since 2000 and more than 5 million people have used it. Mifepristone is used in combination with a second drug, misoprostol, in more than half of all abortions in the U.S.

    The court faced a self-imposed Friday night deadline to decide whether women’s access to a widely used abortion pill would remain unchanged or be restricted while a legal challenge to its Food and Drug Administration approval goes on.

    The justices have been weighing arguments that allowing restrictions contained in lower-court rulings to take effect would severely disrupt the availability of the drug, mifepristone, which is used in the most common abortion method in the United States.

    It has repeatedly been found to be safe and effective, and has been used by more than 5 million women in the U.S. since the FDA approved it in 2000.

    The Supreme Court had initially said it would decide by Wednesday whether the restrictions could take effect while the case continues. A one-sentence order signed by Justice Samuel Alito on Wednesday gave the justices two additional days, without explanation.

    Abortion opponents filed suit in Texas in November, asserting that FDA’s original approval of mifepristone 23 years ago and subsequent changes were flawed.

    Matthew Kacsmaryk, shown listening to a question during his confirmation hearing before the Senate Judiciary Committee in 2017, is the lone federal judge in his north Texas district — a fact that led to speculation among critics that the abortion-pill case had landed in his courtroom via judge shopping.


    Senate Judiciary Committee/AP

    Further context (March 2023): Trump appointee in single-judge federal district in Texas could bar nationwide access to the abortifacient mifepristone

    Also (April 2023): Access to abortion pill in limbo after competing rulings in Texas and Washington

    They won a ruling on April 7 by U.S. District Judge Matthew Kacsmaryk, an appointee of former President Donald Trump, revoking FDA approval of mifepristone. The judge, the lone judge in his Amarillo, Texas, federal district, gave the Biden administration and Danco a week to appeal and seek to keep his ruling on hold.

    Responding to a quick appeal, two more Trump appointees on the 5th U.S. Circuit Court of Appeals said the FDA’s original approval would stand for now. But Judges Andrew Oldham and Kurt Englehardt said most of the rest of Kacsmaryk’s ruling could take effect while the case winds through federal courts.

    MarketWatch contributed.

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  • Supreme Court maintains FDA approval of abortion pill, preserving access for now

    Supreme Court maintains FDA approval of abortion pill, preserving access for now

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    Washington — The Supreme Court on Friday granted a request from the Justice Department to leave in place the Food and Drug Administration’s approval of a widely used abortion pill, preserving access to the drug and reinstating a number of steps by the agency that made it easier to obtain while legal proceedings continue.

    The decision from the conservative court came in the most significant case involving abortion since it overturned Roe v. Wade less than one year ago, a ruling that threw the legal landscape into chaos and led to near-total bans on abortion in more than 12 states. In addition to granting the Justice Department’s request for emergency relief, the Supreme Court also approved a similar request from Danco Laboratories, the maker of the abortion drug mifepristone.

    The Biden administration and Danco turned to the Supreme Court in the legal battle over mifepristone after a federal judge in Texas suspended the FDA’s 23-year-old approval of the drug on April 7, which would have disrupted access to the medication nationwide, including in states where abortion is legal. 

    “The district court countermanded a scientific judgment FDA has maintained across five administrations; nullified the approval of a drug that has been safely used by millions of Americans over more than two decades; and upset reliance interests in a healthcare system that depends on the availability of mifepristone as an alternative to surgical abortion for women who choose to lawfully terminate their early pregnancies,” the Justice Department wrote to the court.

    The Biden administration asked the Supreme Court to pause aspects of a federal appeals court decision that limited how late into a pregnancy mifepristone could be taken, who could prescribe it, and how it could be dispensed. The U.S. Court of Appeals for the 5th Circuit put on hold the most significant part of the district court’s decision — halting the FDA’s approval of mifepristone — but blocked the actions by the agency since in 2016 that relaxed the rules surrounding the drug.

    The appeals court also sped up the Biden administration’s appeal of the district court decision, setting arguments for May 17.

    “If allowed to take effect, the lower courts’ orders would upend the regulatory regime for mifepristone, with sweeping consequences for the pharmaceutical industry, women who need access to the drug, and FDA’s ability to implement its statutory authority,” Solicitor General Elizabeth Prelogar told the court of the decisions from U.S. District Judge Matthew Kacsmaryk and the 5th Circuit.

    Hours after the Justice Department asked the Supreme Court to step in, Justice Samuel Alito issued an administrative stay, which ensured mifepristone would remain available while the court considered the issue. Alito’s order was set to expire at midnight Friday, after which the 5th Circuit’s decision would be in force and limitations on mifepristone would take effect absent action from the high court.

    The dispute over the abortion pill, brought by a conservative legal organization, thrust the Supreme Court back into the center of the national debate over reproductive rights. Further complicating the landscape for abortion access was uncertainty over mifepristone’s availability after the court in Texas and a federal court judge in Washington issued conflicting orders one after another. The 5th Circuit’s ruling days later, which imposed limits on the abortion drug, only added to the confusion.

    Since the Supreme Court rolled back the constitutional right to an abortion last June, more than a dozen states have banned or imposed stringent limits on abortion. In 15 states, restrictions are in place that make it harder for patients to obtain medication abortions, including by requiring the drugs to be provided by a physician.

    Medication abortions have become increasingly common and accounted for more than half of all abortions in the U.S. in 2020, according to the Centers for Disease Control. Mifepristone is taken in combination with a second medicine, misoprostol, to terminate a pregnancy through 10 weeks gestation.

    Since the FDA approved mifepristone in 2000, it has made several changes to the rules surrounding the abortion pill. In 2016, the agency increased the gestational age limit from 7 weeks to 10 weeks, reduced the number of required in-person clinic visits, and broadened the set of healthcare providers to prescribe the drug. In 2019, the FDA approved a generic version of mifepristone and in 2021 lifted  a requirement that the pills be dispensed in-person, which allowed the drug to be prescribed by a provider during telemedicine appointments and sent by mail. Earlier this year, the Biden administration widened the availability of the abortion drug to more retail and online pharmacies.

    The Justice Department has argued in court papers that the risk of serious adverse events from mifepristone is extremely low when it is taken as directed and warned the lower court orders “would scramble the regulatory regime governing a drug that FDA determined was safe and effective under the approved conditions.” More than 5 million women have ended their pregnancies using mifepristone. 

    But in a filing with the Supreme Court, the anti-abortion rights physicians and medical associations who sued the FDA over its approval of mifepristone said the 5th Circuit’s order restores “a modicum of safety” for the pregnant women who use the drug and would not shut off access to mifepristone. Instead, the pill would be subject to the same restrictions in place for the 16 years following its 2000 approval.

    “Both the Fifth Circuit and district court orders paint an alarming picture of this lawlessness — all to the detriment of the women and girls FDA is supposed to protect,” they said.

    The legal battle targeting medication abortion began in November with the lawsuit filed by the Alliance Defending Freedom on behalf of the doctors and medical groups. The challengers argued the FDA failed to adequately consider mifepristone’s health and safety risks when it approved the drug in 2000. The case was filed in the federal court in Amarillo, where only Kacsmaryk, appointed by former President Donald Trump, oversees cases. 

    Kacsmaryk’s decision blocked not only the FDA’s approval of mifepristone, but also the agency’s subsequent actions expanding access to the drug. 

    The 5th Circuit said “it appears that the statute of limitations bars plaintiffs’ challenges to the Food and Drug Administration’s approval of mifepristone in 2000.” But the appeals court said the agency “relied on zero studies that evaluated the safety-and-effectiveness consequences of the” 2016 changes.

    Backing the Biden administration in its push to preserve mifepristone’s FDA approval were 23 blue states and the District of Columbia and 235 Democratic lawmakers, who separately filed friend-of-the-court briefs with the Supreme Court warning the lower courts’ orders would have far-reaching ramifications if allowed to stand.

    “Decades after FDA’s initial approval — yet somehow in an emergency posture — the district court intruded into FDA’s drug approval process, casting a shadow of uncertainty over its decisions,” a group of Democrats in the House and Senate told the court. “The perils of this unwarranted judicial intervention into science-based determinations can hardly be overstated.”

    On the other side of the aisle, 21 red states and 147 Republican lawmakers had urged the Supreme Court to leave the 5th Circuit’s decision in place.

    “By approving and then deregulating chemical abortion drugs, the FDA failed to follow Congress’ statutorily prescribed drug approval process and subverted Congress’ critical public policy interests in upholding patient welfare,” the GOP members of the House and Senate wrote.

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  • It will be

    It will be

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    It will be “very surprising” if Supreme Court blocks abortion pill, Jan Crawford says – CBS News


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    CBS News legal correspondent Jan Crawford tells “Face the Nation” that it would be “surprising” if the Supreme Court agrees with a Texas judge who has blocked access to an abortion pill that was approved by the FDA in 2001. “That’s because there are conservative legal principles that go to the heart of this case,” Crawford said.

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  • Supreme Court puts Texas judge’s abortion pill ruling on hold

    Supreme Court puts Texas judge’s abortion pill ruling on hold

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    Supreme Court puts Texas judge’s abortion pill ruling on hold – CBS News


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    The U.S. Supreme Court on Friday put on hold a ruling last week from a Texas federal judge which halted the FDA’s longtime approval of the abortion drug mifepristone. Caitlin Huey-Burns has the latest.

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  • Governors To Pharmacies: Please Clarify Your Abortion Pill Plans Using Actual Science

    Governors To Pharmacies: Please Clarify Your Abortion Pill Plans Using Actual Science

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    Major pharmacies, including Walgreens and CVS, are at the center of a heated battle over abortion pills in the U.S. ― and the latest salvo comes from 14 Democratic governors calling on pharmacies to clarify their plans to dispense mifepristone, one of the two drugs used for medication abortion.

    “We write in light of recent media reports indicating that some major pharmacy retail companies, faced with political pressure, may be considering not dispensing critical abortion medication to millions of individuals, including in states where medication abortion, like Mifepristone, can be lawfully dispensed,” the governors wrote in a letter released Tuesday morning.

    The letter, addressed to seven major pharmacies in the U.S., is signed by a list of governors including California Gov. Gavin Newsom, Michigan Gov. Gretchen Whitmer, North Carolina Gov. Roy Cooper and Wisconsin Gov. Tony Evers. It was written by the Reproductive Freedom Alliance, a nonpartisan coalition of 21 governors committed to protecting reproductive rights in their states.

    “As companies that dispense critical, life-saving medications, we urge that your decisions continue to be guided by well-established science and medical evidence and a commitment to the health and well-being of patients ― not politics or litigation threats,” the letter says. “The impact to people’s health and lives is too great to do otherwise.” (Scroll down to read the letter in full.)

    Walgreens and CVS announced in January that they would seek certification from the U.S. Food and Drug Administration to start dispensing medication abortion, in the form of the combination of the two drugs mifepristone and misoprostol. Weeks later, however, Walgreens walked back its promise to seek certification, after Republican attorneys general from 20 states sent a letter to the pharmacy threatening to sue if Walgreens attempted to mail abortion pills in their jurisdictions.

    Since then, Democrats and advocates for reproductive rights across the country have been up in arms that Walgreens bowed to political pressure.

    CVS, the biggest pharmacy chain in the U.S., has not commented on whether it will keep its promise to seek FDA approval to begin dispensing mifepristone. Neither Walgreens nor CVS sold abortion pills before this controversy ― they are simply in the process of obtaining certification to do so.

    Medication abortion is the most common way to terminate a pregnancy in the U.S., accounting for over 60% of abortion and miscarriage care in the country. Years of research have shown that medication abortion is extremely safe and effective. When used together, mifepristone and misoprostol are more than 95% effective and safer than Tylenol. The FDA currently approves its use up until 10 weeks of pregnancy, and the World Health Organization says mifepristone can be safely used until 12 weeks.

    The Supreme Court overturned federal abortion protections last year, and more than a dozen states now have near-total abortion bans on the books. The barriers to in-person abortion care in many Southern and Midwestern states have made access to medication abortion even more critical, since in many states the pills can be mailed via telehealth and taken at home.

    Walgreens and CVS are among a number of parties embroiled in the right-wing war on abortion pills. Walgreens may have acquiesced to political pressure in part because of a lawsuit filed in November by a conservative Christian legal group in a federal district court in Texas. The group, Alliance Defending Freedom, claims that the FDA fast-tracked the approval of mifepristone when the department put it on the market in 2000.

    Although legal experts say the arguments in the lawsuit are weak ― citing the 20-plus years that mifepristone has been used widely and safely by millions of Americans ― the lawsuit has teeth because of where it was filed. The conservative group intentionally filed it in Amarillo, Texas, because the district only has one judge: Matthew Kacsmaryk, a far-right Trump appointee with a long track record of opposing abortion rights. The next hearing in the lawsuit against the FDA is scheduled for Wednesday morning.

    Read the letter from 14 Democratic governors below.

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